A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: multipleand pharmacodynamicspharmacodynamics ofrandomizationsafety tolerability
  Phrases that lowered it: healthyinvestigatesubject whosmokingscreening
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Number of arms: 6 (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 26 (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Maximum age: 45 (lowers risk) · Who can join

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS NCT02749097 · started 2013 · scored riskier than 5% of active trials completed
• A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects NCT04802811 · started 2021 · scored riskier than 2% of active trials completed
• A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers NCT04395053 · started 2020 · scored riskier than 0% of active trials completed
• A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject NCT05398510 · started 2022 · scored riskier than 4% of active trials completed
• A SHR0302 BA Study on Healthy Subjects NCT06202612 · started 2024 · scored riskier than 0% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.